|Publication number||US4009720 A|
|Application number||US 05/604,640|
|Publication date||1 Mar 1977|
|Filing date||14 Aug 1975|
|Priority date||14 Aug 1975|
|Publication number||05604640, 604640, US 4009720 A, US 4009720A, US-A-4009720, US4009720 A, US4009720A|
|Inventors||Norman C. Crandall|
|Original Assignee||Shiley Laboratories, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (4), Referenced by (75), Classifications (7), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to tracheotomy tubes and in particular to tracheotomy tubes that incorporates an annular cannula which can be removed for cleaning without removing the exterior of the trachea tube. Tracheotomy tubes have been used to provide a bypass supply of air to the patient when an obstruction occurs within the larynx or the pharynx area, the tracheotomy tube being inserted through an incision which is placed within he patient's neck below the obstructed area.
An important requirement is that the tracheotomy tube provides a bypass air supply to the patient while minimizing the discomfort borne by the patient. Not only is it, of course, desirable to minimize the pain which the patient must suffer, but in addition it is important to minimize movement of the outer cannular once it is installed in the patient's trachea. Otherwise, the trachea are may be irritated by abrasive movement of the outer cannula. Therefore, it is important that the inner cannula be attached and detached from the outer cannula with a minimum of force exerted upon the outer cannula. Also, it is important that the air connector be allowed a degree of rotational freedom relative to the inner and outer cannulae such that normal movement of the patient relative to the air line is tolerated without exerting any torque forces upon the outer cannula.
Heretofore, there has not been available a tracheotomy tube which maintains an air tight seal between both the inner and outer cannulae and between the inner cannula and the coupling connector while at the same time allowing for easy removability of the inner cannula as well as rotational movement of the air coupling with respect to the inner cannula. For example, the prior art includes sealing arrangements positioned at various locations along the trachea tube toward the distal end and are of such a tight nature that it is necessary to apply a significant amount of force to be able to remove the inner cannula from the outer cannula. Some prior art sealing arrangements use a ridge on the inner cannula which is of a greater diameter than the interior diameter of the outer cannula. This enlarged ridge is designed to snap into a recessed ring within the interior surface of the outer cannula. These prior art sealing arrangements require that a significant amount of force be exerted upon the inner cannula in order to remove it from the outer cannula. This force results in great discomfort to the patient and irritation to the trachea area, because the outer cannula is being moved and jerked during this sealing and unsealing process.
The present invention comprises a wedge-like seal having a central ridge circumferentially around the inner cannula from which depend two frusto-conical sealing surfaces in opposite directions to provide the necessary sealing of the gap between the inner cannula and the outer cannula as well as the gap between the inner cannula and the coupling. At least part of one of the frusto-conical sealing surfaces has a diameter which is greater than the diameter of the interior of the outer cannula, so that pressing the frusto-conical surface into the interior conduit or bore of the outer cannula will result in a tight engagement between the frusto-conical surface and the outer edge of the bore in the outer cannula. Similarly, a portion of the other frusto-conical sealing surface has a diameter greater than the internal diameter of the coupling connector adjacent its juncture with the outer cannula, so that movement of the coupling connector over the wedge seal will result in a tight air seal between the other frusto-conical sealing surface and the edge of the internal conduit of the connector coupling facing the outer cannula.
A significant feature of the present invention is that it seals the junction between the outer cannula and the coupling connector to prevent any leakage of either incoming or expelling air that may become entrapped in the gaps between the respective outer cannula and coupling with the inner cannula. An equally significant feature of the invention is that this air tight seal is effected with relative little force being required to attach the inner cannula to the outer cannula while essentially no force on the outer cannula is required to remove and unseal the inner cannula.
The novel tracheotomy tube seal disclosed herein also has the advantage of being compatible with a snap on connector such as we have disclosed in a patent application entitled "A Snap Lock Connector For A Tracheotomy Tube", applicant's attorney's docket number 2808, to be filed subsequently. As set out in this referenced patent application, the snap lock connector is designed to be able to axially rotate about both the inner and outer cannulae. This is an important feature necessary to the comfort of the patient, because when he is moving around in his bed, the air line connected to the connector sometimes twists which would tend to twist the tracheotomy tube in the patient's trachea causing discomfort. The frusto-conical shape of the sealing surface provides the ability for the connector to axially rotate while still maintaining the proper seal with the inner cannula.
FIG. 1 is a perspective view of the tracheotomy tube assembly;
FIG. 2 is a perspective view of the tracheotomy tube assembly with the inner cannula partially removed;
FIG. 3 is a partial sectional view through the coupling connector and the outer ends of the inner and outer cannulae; and
FIG. 4 is a sectional view through a portion of the seal.
With respect to FIG. 1, a tracheotomy tube assembly 10 is shown with an outer cannula 12 and a sealing balloon 14 located adjacent the distal end 16 of the outer cannula 12. The sealing balloon 14 is advantageously constructed in accordance with the teachings of U.S. Pat. Nos. 3,659,612 and 3,693,624. Positioned adjacent the proximal end 18 of the outer cannula is a swivel neck flange 20 which is used to secure the assembly to the neck of the patient. A flexible inflation tube 22 extends from the proximal end 18 of the outer cannula to receive air to inflate the balloon 14 for sealing the outer cannula 12 within the trachea of the patient. Removably attached to the proximal end of the outer cannula 12 is a coupling or connector 24 having a pair of connection fingers 26 which are anchored on the rim 28 of the proximal end 18 of the outer cannula 12.
FIG. 2 shows the inner cannula 30 partially removed from within the bore 32 of the outer cannula 12. The inner cannula 30 is designed to be completely removed from within the outer cannula 12 in order to cleanse the inner cannula periodically to provde a clean and clear passage for the flow of air to the patient. The coupling 24 in FIG. 3 is permanently affixed to the proximal end 34 of the inner cannula 30, but is able to axially rotate about the inner cannula in order to allow any twisting motion of the air supply line (not shown) which would be connected to the coupling 24 while not causing the twisting of the inner or outer cannula which are located in the patient's trachea.
The connection of the coupling 24 to the proximal end 34 of the inner cannula 30 is shown more clearly in FIG. 3. The coupling 24 has a conduit or passageway 36 which receives an air supply from an outside source. The bore or internal conduit 32 of the outer cannula 12 receives the inner cannula 30. It should be noted that the inner conduit 34 of the inner cannula 30. This is in order to allow for the anchoring of the retaining ring 38 at the proximal end 34 of the inner cannula. Consequently, the proximal end 34 of the inner cannula 30 is permanently connected to the cannula end 40 of the coupling 24.
It should be noted that the exterior diameter of the inner cannula 30 is less than the diameter of the bore or conduit 32 of the outer cannula 12. Consequently, there is a small circumferential gap 42 which exists between the interior surface of the bore 32 of the outer cannula 12 and the exterior surfaces of the inner cannula 30. Similarly, the exterior diameter of the inner cannula 30 is less than the inner diameter of the necked down portion 44 of the conduit 36 in the coupling 24, so that there is a small circumferential gap 46 which exists between the coupling 24 and the inner cannula 30.
Integrally formed on the inner cannula 30 adjacent the proximal end 34 is wedge-like double surfaced seal 48. The seal is comprised of a main ring or ridge 50 which circumferentially surrounds the inner cannula 30 and has an exterior diameter which is greater than either the interior diameter of the conduit which is greater than either the interior diameter of the conduit 32 in the outer cannula 12 or the diameter of the interior conduit 44 of the coupling 14. The seal 48 is preferably made of clear polypropylene and it is preferably molded integrally within the inner cannula 30 adjacent its proximal end 34. Extending from one side of the ring 50 toward the outer cannula 12 is a frusto-conical surface 52 extending in a longitudinal direction with respect to the inner cannula 30. It should be noted that at least a portion of the frusto-conical or wedge-like sealing surface 52 has an exterior diameter which is greater than the interior diameter of the bore 32 of the outer cannula 12. Consequently, as the surface 52 is moved into the bore 32, the proximal edge 54 of the conduit 32 will seal tightly against the surface 52.
Extending in a direction opposite from the central ring 50 in a direction toward the connector 24 is a second frustoconical sealing surface 56 of which at least a portion has a greater diameter than the diameter of the necked down conduit 44 of the coupling 24. Therefore, the movement of the cannula side edge 60 of the conduit portion 44 onto the wedge-like sealing surface 56 will result in a tight seal between the coupling 24 and the inner cannula 30. The ring 50 acts as a guard to prevent the insertion of the inner cannula 30 into the outer cannula 12 from being beyond the sealing surface 52. Similarly, the ring 50 prevents the coupling 24 from going beyond the sealing surface 56 when the coupling is moved onto the proximal end 34 of the inner cannula.
It has been determined with respect to the slope of the sealing surface 52 and 56 that an angle of fifteen degrees with respect to the longitudinal axis A of the proximal end of the inner cannula is a satisfactory incline. The slope of the sealing surface is shown more clearly on FIG. 4. If the angle were made too large, the desired wedge-like seal operation would be lost. On the other hand, if the angle is too small, the sealing surfaces would become longer than desired. Because tracheotomy tubes are made of various sizes to accommodate various individuals, the sealing surface 52 may extend down from the central ridge 50 at a greater radial distance on the central ridge than the other sealing surface 56 as shown in FIG. 4.
Turning to the procedural use of the present invention, reference is made to FIGS. 1 through 3. The outer cannula 12 is placed in the patient's trachea. The inner cannula 30 with the coupling 24 is inserted into the bore 32 of the outer cannula located in the patient's trachea. The coupling 24 is free to axially rotate about the longitudinal axis A of the proximal end 34 of the inner cannula 30. The inner cannula is inserted into the outer cannula far enough so that the connecting fingers 26 can hook over the restraining surface 62 of the rim 28. However, coincidentally with the hooking of the fingers 26 over the rim 28 is the sealing contact of not only the proximal edge 54 of the bore 32 with the one sealing surface 52, but also the cannula facing edge 60 of the coupling 24 with the other sealing surface 56. This sealing operation is similar in principle to inserting a cone into the end of a tube to plug the end of the tube with the diameter of part of the cone being greater than the diameter of the tube. In order to accomplish this sealing engagement some slight force is directed toward the proximal end 18 of the outer cannula. However, because the swivel neck flange 20 receives this force and distributes it over the large area of the patient's outer neck surface, there is no discomfort to the patient. The patient's trachea receives no irritating movement of the outer cannula.
When the inner cannula 30 is to be removed from within the outer cannula 12, the locking or connecting fingers 26 are pivotally disengaged from the surface 62 of the rim 28 and the inner cannula 30 is simply withdrawn. The patient does not experience any forces which would tend to move the outer cannula and cause discomfort.
Consequently, as a result of the above unique sealing arrangement, the air which is introduced to the inner cannula from the outside air source through the coupling 24 will not leak at the junction of the inner cannula and the coupling. The tight seal between the sealing surface 56 and the edge 60 will prevent any flow of air leaking through the gap 46 and out into the area 62 between the coupling 24 and the outer cannula 12. Also any air which enters the gap 42 between the inner cannula 30 and the outer cannula 12 from the distal end of both cannulas will be prevented from flowing into the area 62 because of the tight seal between the sealing surface 52 and the edge 54.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2310944 *||9 Sep 1940||16 Feb 1943||James L Douglass||Tube coupling|
|US3169529 *||27 May 1963||16 Feb 1965||Koenig Norman Z||Tracheostomy tube|
|US3688774 *||5 Oct 1970||5 Sep 1972||Taichiro Akiyama||Tracheotomy cannula and supporter thereof|
|US3693624 *||2 Oct 1969||26 Sep 1972||Donald P Shiley||Tracheotomy tube|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US4152017 *||8 Aug 1977||1 May 1979||Metatech Corporation||Swivel connector for endotracheal tube or the like|
|US4278081 *||21 Feb 1978||14 Jul 1981||Jones James W||Tracheal tube|
|US4315505 *||7 Apr 1980||16 Feb 1982||Shiley, Inc.||Tracheostomy tube with disposable inner cannula|
|US4449523 *||13 Sep 1982||22 May 1984||Implant Technologies, Inc.||Talking tracheostomy tube|
|US4573460 *||15 May 1984||4 Mar 1986||Implant Technologies||Talking tracheostomy tube|
|US4596248 *||23 Nov 1984||24 Jun 1986||Lieberman Edgar M||Tracheostomy device|
|US4627433 *||3 Mar 1986||9 Dec 1986||Lieberman Edgar M||Tracheostomy device|
|US4633864 *||22 Oct 1984||6 Jan 1987||Dacomed Corporation||Speaking endotracheal tube|
|US4635967 *||29 Mar 1985||13 Jan 1987||Kawasaki Thermal Systems, Inc.||Internal seal for insulated steam injection casing assembly|
|US4664427 *||1 Apr 1985||12 May 1987||Master Industries, Inc.||Quick connect fitting|
|US4817598 *||8 Jun 1987||4 Apr 1989||Portex, Inc.||Tracheostomy tube with ring pull removable inner cannula|
|US5022392 *||1 Oct 1990||11 Jun 1991||Yeakel Joseph D||Apparatus for secretion deflection during intubation|
|US5056515 *||4 Jan 1991||15 Oct 1991||Abel Elaine R||Tracheostomy tube assembly|
|US5201725 *||26 Sep 1991||13 Apr 1993||Ivac||Needle free i.v. adapter|
|US5361754 *||25 Jan 1993||8 Nov 1994||Mallinckrodt Medical, Inc.||Apparatus and method for connecting a tracheostomy tube to a neckplate|
|US5443063 *||31 Aug 1993||22 Aug 1995||The Johns Hopkins University||Cuffed oro-pharyngeal airway|
|US5505198 *||28 Jul 1994||9 Apr 1996||Siebens; Arthur A.||Unidirectional airflow tracheotomy valve|
|US5653229 *||9 May 1995||5 Aug 1997||Johns Hopkins University||Cuffed oro-pharyngeal airway|
|US5778877 *||5 Jun 1995||14 Jul 1998||Mallinckrodt Medical, Inc.||Apparatus and method for connecting a tracheostomy tube to a neckplate|
|US5819734 *||16 Dec 1992||13 Oct 1998||Mallinckrodt Medical, Inc.||Neck flange for holding a tracheostomy tube in place and allowing limited movement therebetween and tracheostomy procedure using the same|
|US6053167 *||13 Apr 1996||25 Apr 2000||Tracoe Gesellschaft fu medizinische||Tracheostomy cannula|
|US6135110 *||22 Apr 1998||24 Oct 2000||Sims Portex Inc.||Tracheostomy tube|
|US6248099||14 May 1998||19 Jun 2001||Medcare Medical Group, Inc.||Disposable tracheostomy inner cannula connector|
|US6588427||25 Feb 2002||8 Jul 2003||Kimberly-Clark Worldwide, Inc.||Heat and moisture exchanger adapter to closed suction catheter assembly and system having improved catheter cleaning|
|US6662804||15 Jan 2002||16 Dec 2003||Antonio Ortiz||Tracheostomy tube with cuff on inner cannula|
|US6698424||21 Dec 2001||2 Mar 2004||Kimberly-Clark Worldwide, Inc.||Medical connector for a respiratory assembly|
|US6769430||31 Oct 2000||3 Aug 2004||Kimberly-Clark Worldwide, Inc.||Heat and moisture exchanger adaptor for closed suction catheter assembly and system containing the same|
|US7086402 *||4 Oct 2005||8 Aug 2006||Transtracheal Systems, Inc.||Tracheal tube/tracheal catheter adaptor cap|
|US7549419||23 Jun 2004||23 Jun 2009||Kimberly-Clark Worldwide, Inc.||Heat and moisture exchanger adaptor for closed suction catheter assembly and system containing the same|
|US7730839||23 Feb 2007||8 Jun 2010||The United States Of America As Represented By The Secretary Of The Army||Interfacial stress reduction and load capacity enhancement system|
|US8313687||8 Sep 2008||20 Nov 2012||Kimberly-Clark Worldwide, Inc.||Method of making an improved balloon cuff tracheostomy tube|
|US8353315 *||23 Aug 2010||15 Jan 2013||Lg Chem, Ltd.||End cap|
|US8464718||16 Feb 2011||18 Jun 2013||Covidien Lp||Neck flange attachment apparatuses for tracheostomy tubes|
|US8469404||23 Aug 2010||25 Jun 2013||Lg Chem, Ltd.||Connecting assembly|
|US8485193 *||30 Mar 2007||16 Jul 2013||Lazarus Medical, LLC||Ventilator to tracheotomy tube coupling|
|US8511309||22 Jun 2011||20 Aug 2013||Brian D. Worley||Ventilator to tracheotomy tube coupling|
|US8607795||8 Sep 2008||17 Dec 2013||Kimberly-Clark Worldwide, Inc.||Balloon cuff tracheostomy tube|
|US8758922||23 Aug 2010||24 Jun 2014||Lg Chem, Ltd.||Battery system and manifold assembly with two manifold members removably coupled together|
|US8920956||23 Aug 2010||30 Dec 2014||Lg Chem, Ltd.||Battery system and manifold assembly having a manifold member and a connecting fitting|
|US8974934||16 Aug 2012||10 Mar 2015||Lg Chem, Ltd.||Battery module|
|US8978656 *||28 Dec 2011||17 Mar 2015||Apex Medical Corp.||Tube-positioning device for a breathing mask|
|US9027561 *||23 May 2008||12 May 2015||Smiths Group Plc||Medico-surgical tube assemblies|
|US9433739 *||7 Jun 2013||6 Sep 2016||Vitaltec Corporation||Inner type tracheostomy tube|
|US20040255952 *||23 Jun 2004||23 Dec 2004||Kimberly-Clark Worldwide, Inc.||Heat and moisture exchanger adaptor for closed suction catheter assembly and system containing the same|
|US20060070627 *||4 Oct 2005||6 Apr 2006||Peterson Leslie W||Tracheal tube/tracheal catheter adaptor cap|
|US20070181130 *||6 Feb 2006||9 Aug 2007||Worley Brian D||Ventilator to tracheotomy tube coupling|
|US20070181132 *||30 Mar 2007||9 Aug 2007||Worley Brian D||Ventilator to tracheotomy tube coupling|
|US20090064999 *||12 Sep 2007||12 Mar 2009||E. Benson Hood Laboratories||Tracheostomy tube with inner cannula and obturator for regular and extra-long stomas|
|US20090090365 *||8 Sep 2008||9 Apr 2009||Cuevas Brian J||Balloon cuff tracheostomy tube with greater ease of insertion|
|US20090090366 *||8 Sep 2008||9 Apr 2009||Cuevas Brian J||Balloon cuff tracheostomy tube|
|US20090091066 *||8 Sep 2008||9 Apr 2009||Michael Sleva||Method of making an improved balloon cuff tracheostomy tube|
|US20090209908 *||8 Sep 2008||20 Aug 2009||Cuevas Brian J||Tubular workpiece for producing an improved balloon cuff tracheostomy tube|
|US20100089403 *||23 May 2008||15 Apr 2010||Caroline Therese Solly||Medico-surgical tube assemblies|
|US20100307488 *||16 Oct 2006||9 Dec 2010||Unomedical A/S||Tracheostomy Tube Assembly|
|US20110083672 *||12 Aug 2010||14 Apr 2011||Vanderbilt University||Tracheostomy tube having a cuffed inner cannula|
|US20130068231 *||28 Dec 2011||21 Mar 2013||Chih-Tsan CHIEN||Tube-positioning device for a breathing mask|
|US20130269690 *||7 Jun 2013||17 Oct 2013||Vitaltec Corporation||Inner Type Tracheostomy Tube|
|DE3300203A1 *||5 Jan 1983||5 Jul 1984||Zinon Dr Med Douvlis||Tracheal tube having connecting and fixing devices|
|DE3819237A1 *||6 Jun 1988||22 Dec 1988||Portex Inc||Endotrachealtubus|
|DE19514433C1 *||24 Apr 1995||4 Jan 1996||Franz Prof Dr Med Waldeck||Tracheostomy cannula for insertion into tracheostoma|
|DE102014003362A1 *||6 Mar 2014||10 Sep 2015||Primed Halberstadt Medizintechnik Gmbh||Trachealkanüleninnenrohr|
|EP0037719A1 *||2 Apr 1981||14 Oct 1981||Shiley Incorporated||Tracheostomy tube with disposable inner cannula|
|EP0107779A1 *||2 Apr 1981||9 May 1984||Shiley Incorporated||Tracheostomy tube with disposable inner cannula|
|EP0691136A3 *||11 May 1993||31 Jan 1996||Jeppesen Finn||Title not available|
|EP0713405A1 *||8 Aug 1994||29 May 1996||Mallinckrodt Medical, Inc.||Connector for locking an inner cannula inside an outer cannula|
|EP0713405A4 *||8 Aug 1994||26 Mar 1997||Mallinckrodt Medical Inc||Connector for locking an inner cannula inside an outer cannula|
|EP1738788A1 *||27 Jun 2006||3 Jan 2007||Primed Halberstadt Medizintechnik Gmbh||Tracheal tube with pivotable connector|
|EP1981599A2 *||29 Jan 2007||22 Oct 2008||Brian D. Worley||Ventilator to tracheotomy tube coupling|
|EP1981599A4 *||29 Jan 2007||6 Nov 2013||Brian D Worley||Ventilator to tracheotomy tube coupling|
|WO1991005579A1 *||18 Oct 1990||2 May 1991||Pharma Systems Ps Ab||Arrangement for protecting the breathing passages of laryngectomees|
|WO1991007202A1 *||16 Nov 1990||30 May 1991||Kensey Nash Corporation||A percutaneous transtracheal airway device and procedure|
|WO1993023103A1 *||11 May 1993||25 Nov 1993||Finn Jeppesen||Tracheotomy cannula|
|WO2007092199A2||29 Jan 2007||16 Aug 2007||Worley Brian D||Ventilator to tracheotomy tube coupling|
|WO2008046418A1 *||16 Oct 2006||24 Apr 2008||Unomedical A/S||A tracheostomy tube assembly|
|WO2015131867A1||19 Feb 2015||11 Sep 2015||Primed Halberstadt Medizintechnik Gmbh||Tracheal cannula inner tube|
|U.S. Classification||128/207.15, 285/334.2|
|Cooperative Classification||A61M16/0427, A61M16/0497, A61M16/0465|
|29 Oct 1992||AS||Assignment|
Owner name: SORIN BIOMEDICAL INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:SHILEY INCORPORATED;REEL/FRAME:006289/0029
Effective date: 19920226
|22 Dec 1992||AS||Assignment|
Owner name: TRACHEOSTOMY PRODUCTS, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:SORIN BIOMEDICAL INC.;REEL/FRAME:006348/0886
Effective date: 19921216
|18 Jul 1994||AS||Assignment|
Owner name: MALLINCKRODT MEDICAL, INC., MISSOURI
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:TRACHEOSTOMY PRODUCTS, INC.;REEL/FRAME:007061/0274
Effective date: 19940628